BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500 STAT TROPONIN I

    MDR report key: 1642584 · Received March 24, 2010

    Report

    Report Number
    2017183-2010-00013
    Event Type
    Other
    Date Received
    March 24, 2010
    Date of Event
    March 10, 2010
    Report Date
    March 10, 2010
    Manufacturer
    SIMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JHX
    PMA / PMN Number
    K034055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM EVALUATION. ANALYSIS OF THE SYSTEM BY THE FSE INDICATES THAT THERE ARE NO KNOWN CAUSES FOR THE DISCORDANT POSITIVE IMMULITE 2500 TROPONIN RESULT. THE FSE PERFORMED A FUNCTIONAL SYSTEM CHECK AND OPTIMIZED THE WASH STATION DQA TESTS WITH THE SPIN SPEED. THE INSTRUMENT IS PERFORMING WITH SPECIFICATIONS.

    Description of Event or Problem · 1

    A DISCORDANT POSITIVE IMMULITE 2500 STAT TROPONIN ASSAY RESULT WAS OBTAINED ON A PT SAMPLE WHEN COMPARED TO ANOTHER TROPONIN TEST METHOD. THE DISCORDANT POSITIVE TROPONIN RESULTS WERE NOT RELEASED AND NEGATIVE TROPONIN RESULTS WERE REPORTED FOR BOTH PT SAMPLES. THERE WAS NO KNOWN REPORT OF PT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT POSITIVE STAT TROPONIN ASSAY RESULTS FOR BOTH PT SAMPLES.

    Additional Manufacturer Narrative · 2

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM EVALUATION. ANALYSIS OF THE SYSTEM BY THE FSE INDICATES THAT THERE ARE NO KNOWN CAUSES FOR THE DISCORDANT POSITIVE IMMULITE 2500 TROPONIN RESULT. THE FSE PERFORMED A FUNCTIONAL SYSTEM CHECK AND OPTIMIZED THE WASH STATION DQA TESTS WITH THE SPIN SPEED. THE INSTRUMENT IS PERFORMING WITH SPECIFICATIONS.

    Description of Event or Problem · 2

    A FALSE POSITIVE IMMULITE 2500 STAT TROPONIN ASSAY RESULT TROPONIN RESULT WAS OBTAINED ON A SECOND PT SAMPLE WHEN COMPARED TO ANOTHER TROPONIN TEST METHOD AND REPEAT TESTING. THE DISCORDANT POSITIVE TROPONIN RESULTS WERE NOT RELEASED AND NEGATIVE TROPONIN RESULTS WERE REPORTED FOR BOTH PT SAMPLES. THERE WAS NO KNOWN REPORT OF PT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT POSITIVE STAT TROPONIN ASSAY RESULTS FOR BOTH PT SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2500 STAT TROPONIN I TROPONIN IMMUNOASSAY JHX SIMENS HEALTHCARE DIAGNOSTICS INC. NA 202

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK
    2 UNK